82 FR 42818 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 175 (September 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 175 (September 12, 2017)
| Page Range | 42818-42819 | |
| FR Document | 2017-19261 |
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)] [Notices] [Pages 42818-42819] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19261] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4515] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of August 14, 2017. In the notice, FDA requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice published August 14, 2017 (82 FR 37866). Submit either electronic or written comments by September 20, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 20, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a [[Page 42819]] third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-4515 for ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Extension of Comment Period.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff Office between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of August 14, 2017, FDA published a notice with a 30-day comment period to request comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. The Agency has received requests for an extension of the comment period for the notice. Each request conveyed concern that the current 30-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. FDA has considered the requests and is extending the comment period for the notice until September 20, 2017. The Agency believes this extension allows adequate time for interested persons to submit comments. Dated: September 7, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19261 Filed 9-11-17; 8:45 am] BILLING CODE 4164-01-P
![42818 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices
of QSIT, and informed by the PMA CtQ to the Web sites after this document DEPARTMENT OF HEALTH AND
information developed jointly by FDA publishes in the Federal Register.) HUMAN SERVICES
and the PMA applicant. 1. Implantable Devices that Contain Batteries
7. Following completion of the Critical to Quality Inspection Pilot.
Food and Drug Administration
inspection, participating FDA Offices Available at https://www.fda.gov/ [Docket No. FDA–2017–N–4515]
and applicants provide the information/ downloads/MedicalDevices/
data needed to assess the voluntary DeviceRegulationandGuidance/ International Drug Scheduling;
PMA CtQ pilot program’s impact on MedicalDeviceQualityandCompliance/ Convention on Psychotropic
resource utilization and quality focus, UCM469128.pdf. Substances; Single Convention on
utilizing the evaluation forms provided 2. FDA’s Case for Quality, available at http:// Narcotic Drugs; Ocfentanil,
in Appendices A and B (Ref. 11). www.fda.gov/MedicalDevices/ Carfentanil, Pregabalin, Tramadol,
During this voluntary PMA CtQ pilot DeviceRegulationandGuidance/ Cannabidiol, Ketamine, and Eleven
program, CDRH staff intends to be MedicalDeviceQualityandCompliance/ Other Substances; Extension of
available to answer questions or ucm378185.htm. Comment Period
concerns that may arise. The voluntary 3. FDA’s Guide to Inspections of Quality
PMA CtQ pilot program participants Systems, Quality System Inspection AGENCY: Food and Drug Administration,
will be asked to comment on and Technique, available at http:// HHS.
discuss their experiences with the PMA www.fda.gov/ICECI/Inspections/ ACTION: Notice; extension of comment
CtQ pilot submission process. InspectionGuides/ucm074883.htm. period.
Comments and discussions may assist 4. FDA Guidance for Industry and FDA Staff
‘‘Requests for Feedback on Medical SUMMARY: The Food and Drug
FDA in determining whether the goals
Device Submissions: The Pre- Administration (FDA or the Agency) is
of this voluntary PMA CtQ pilot
Submission Program and Meetings with extending the comment period for the
program goal are clearly communicated notice that appeared in the Federal
Food and Drug Administration Staff’’
and attainable. Register of August 14, 2017. In the
dated February 18, 2014. Available at
II. Duration of the Premarket Approval https://www.fda.gov/ucm/groups/fdagov- notice, FDA requested comments
Application Critical to Quality Pilot public/@fdagov-meddev-gen/documents/ concerning abuse potential, actual
Program document/ucm311176.pdf. abuse, medical usefulness, trafficking,
5. FDA’s Guidance for Industry and FDA and impact of scheduling changes on
FDA intends to accept requests for Staff: Acceptance and Filing Reviews for
participation in the voluntary PMA CtQ availability for medical use of 17 drug
Premarket Approval Applications substances. The Agency is taking this
pilot program from September 29, 2017, (PMAs) at https://www.fda.gov/ucm/
to December 31, 2018, or until such time action in response to requests for an
groups/fdagov-public/@fdagov-meddev- extension to allow interested persons
as when a total of nine PMAs have been gen/documents/document/
enrolled. additional time to submit comments.
ucm313368.pdf.
DATES: FDA is extending the comment
III. Paperwork Reduction Act of 1995 6. FDA’s Guidance for Industry and FDA
Staff: Quality System Information for period on the notice published August
This notice refers to previously Certain Premarket Application Reviews, 14, 2017 (82 FR 37866). Submit either
approved collections of information available at http://www.fda.gov/ electronic or written comments by
found in FDA regulations. These medicaldevices/ September 20, 2017.
collections of information are subject to deviceregulationandguidance/ ADDRESSES: You may submit comments
review by the Office of Management and guidancedocuments/ucm070897.htm. as follows. Please note that late,
Budget (OMB) under the Paperwork 7. FDA’s Official Action Indicated, available untimely filed comments will not be
Reduction Act of 1995 (44 U.S.C. 3501– at http://www.fda.gov/downloads/ considered. Electronic comments must
3520). The collections of information in AboutFDA/Transparency/ be submitted on or before September 20,
21 CFR part 814, subparts A through E PublicDisclosure/ 2017. The https://www.regulations.gov
have been approved under OMB control GlossaryofAcronymsandAbbreviations/ electronic filing system will accept
number 0910–0231; the collections of UCM212061.pdf. comments until midnight Eastern Time
information in 21 CFR part 820 have 8. 2017 FDA Investigations Operations at the end of September 20, 2017.
been approved under OMB control Manual (IOM) Chapter 5 at https://
Comments received by mail/hand
www.fda.gov/ucm/groups/fdagov-public/
number 0910–0073; and the collections delivery/courier (for written/paper
@fdagov-afda-ice/documents/document/
of information in ‘‘Requests for submissions) will be considered timely
ucm123522.pdf.
Feedback on Medical Device 9. FDA Compliance Program 7383.001 at if they are postmarked or the delivery
Submissions: The Pre-Submission http://www.fda.gov/downloads/ service acceptance receipt is on or
Program and Meetings with Food and MedicalDevices/ before that date.
Drug Administration Staff’’ have been DeviceRegulationandGuidance/
approved under OMB control number Electronic Submissions
MedicalDeviceQualityandCompliance/
0910–0756. UCM295570.pdf. Submit electronic comments in the
10. FDA Compliance Program 7382.845 at following way:
IV. References • Federal eRulemaking Portal:
https://www.fda.gov/downloads/
The following references have been MedicalDevices/ https://www.regulations.gov. Follow the
placed on display in the Division of DeviceRegulationandGuidance/ instructions for submitting comments.
pmangrum on DSK3GDR082PROD with NOTICES1
Dockets Management (see ADDRESSES), GuidanceDocuments/UCM244277.pdf. Comments submitted electronically,
and may be seen by interested persons 11. Appendices A and B. including attachments, to https://
between 9 a.m. and 4 p.m., Monday Dated: September 5, 2017.
www.regulations.gov will be posted to
through Friday, and are available the docket unchanged. Because your
Leslie Kux,
electronically at https:// comment will be made public, you are
www.regulations.gov. (FDA has verified Associate Commissioner for Policy. solely responsible for ensuring that your
the Web site addresses, but we are not [FR Doc. 2017–19258 Filed 9–11–17; 8:45 am] comment does not include any
responsible for any subsequent changes BILLING CODE 4164–01–P confidential information that you or a
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![Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42819
third party may not wish to be posted, https://www.regulations.gov. Submit DEPARTMENT OF HEALTH AND
such as medical information, your or both copies to the Dockets Management HUMAN SERVICES
anyone else’s Social Security number, or Staff. If you do not wish your name and
confidential business information, such contact information to be made publicly Food and Drug Administration
as a manufacturing process. Please note available, you can provide this [Docket No. FDA–2016–D–0734]
that if you include your name, contact information on the cover sheet and not
information, or other information that in the body of your comments and you Evaluation and Reporting of Age,
identifies you in the body of your must identify this information as Race, and Ethnicity Data in Medical
comments, that information will be ‘‘confidential.’’ Any information marked Device Clinical Studies; Guidance for
posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed Industry and Food and Drug
• If you want to submit a comment except in accordance with 21 CFR 10.20 Administration Staff; Availability
with confidential information that you and other applicable disclosure law. For
do not wish to be made available to the AGENCY: Food and Drug Administration,
more information about FDA’s posting
public, submit the comment as a HHS.
of comments to public dockets, see 80
written/paper submission and in the FR 56469, September 18, 2015, or access ACTION: Notice of availability.
manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/
Submissions’’ and ‘‘Instructions’’). SUMMARY: The Food and Drug
fdsys/pkg/FR-2015-09-18/pdf/2015- Administration (FDA or Agency) is
Written/Paper Submissions 23389.pdf. announcing the availability of the
Submit written/paper submissions as Docket: For access to the docket to guidance entitled ‘‘Evaluation and
follows: read background documents or the Reporting of Age, Race, and Ethnicity
• Mail/Hand delivery/Courier (for electronic and written/paper comments Data in Medical Device Clinical
written/paper submissions): Dockets received, go to https:// Studies.’’ The purpose of this document
Management Staff (HFA–305), Food and www.regulations.gov and insert the is to outline FDA’s recommendations
Drug Administration, 5630 Fishers docket number, found in brackets in the and expectations for the evaluation and
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the reporting of age, race, and ethnicity data
• For written/paper comments ‘‘Search’’ box and follow the prompts in medical device clinical studies. The
submitted to the Dockets Management and/or go to the Dockets Management primary intent of these
Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, Rm. 1061, recommendations is to improve the
well as any attachments, except for Rockville, MD 20852. quality, consistency, and transparency
information submitted, marked and of data regarding the performance of
identified, as confidential, if submitted FOR FURTHER INFORMATION CONTACT: medical devices within specific age,
as detailed in ‘‘Instructions.’’ James R. Hunter, Center for Drug race, and ethnic groups.
Instructions: All submissions received Evaluation and Research, Controlled DATES: The announcement of the
must include the Docket No. FDA– Substance Staff, Food and Drug guidance is published in the Federal
2017–N–4515 for ‘‘International Drug Administration, 10903 New Hampshire Register on September 12, 2017.
Scheduling; Convention on Ave., Bldg. 51, Rm. 5150, Silver Spring, ADDRESSES: You may submit either
Psychotropic Substances; Single MD 20993–0002, 301–796–3156, email: electronic or written comments on
Convention on Narcotic Drugs; james.hunter@fda.hhs.gov. Agency guidances at any time as
Ocfentanil, Carfentanil, Pregabalin, SUPPLEMENTARY INFORMATION: In the follows:
Tramadol, Cannabidiol, Ketamine, and Federal Register of August 14, 2017,
Eleven Other Substances; Extension of Electronic Submissions
FDA published a notice with a 30-day
Comment Period.’’ Received comments, comment period to request comments Submit electronic comments in the
those filed in a timely manner (see on abuse potential, actual abuse, following way:
ADDRESSES), will be placed in the docket medical usefulness, trafficking, and • Federal eRulemaking Portal:
and, except for those submitted as impact of scheduling changes on https://www.regulations.gov. Follow the
‘‘Confidential Submissions,’’ publicly availability for medical use of 17 drug instructions for submitting comments.
viewable at https://www.regulations.gov substances. Comments submitted electronically,
or at the Dockets Management Staff including attachments, to https://
Office between 9 a.m. and 4 p.m., The Agency has received requests for www.regulations.gov will be posted to
Monday through Friday. an extension of the comment period for the docket unchanged. Because your
• Confidential Submissions—To the notice. Each request conveyed comment will be made public, you are
submit a comment with confidential concern that the current 30-day solely responsible for ensuring that your
information that you do not wish to be comment period does not allow comment does not include any
made publicly available, submit your sufficient time to develop a meaningful confidential information that you or a
comments only as a written/paper or thoughtful response to the notice. third party may not wish to be posted,
submission. You should submit two FDA has considered the requests and such as medical information, your or
copies total. One copy will include the is extending the comment period for the anyone else’s Social Security number, or
information you claim to be confidential notice until September 20, 2017. The confidential business information, such
with a heading or cover note that states Agency believes this extension allows as a manufacturing process. Please note
‘‘THIS DOCUMENT CONTAINS adequate time for interested persons to that if you include your name, contact
pmangrum on DSK3GDR082PROD with NOTICES1
CONFIDENTIAL INFORMATION.’’ The submit comments. information, or other information that
Agency will review this copy, including identifies you in the body of your
Dated: September 7, 2017.
the claimed confidential information, in comments, that information will be
its consideration of comments. The Anna K. Abram,
posted on https://www.regulations.gov.
second copy, which will have the Deputy Commissioner for Policy, Planning, • If you want to submit a comment
claimed confidential information Legislation, and Analysis. with confidential information that you
redacted/blacked out, will be available [FR Doc. 2017–19261 Filed 9–11–17; 8:45 am] do not wish to be made available to the
for public viewing and posted on BILLING CODE 4164–01–P public, submit the comment as a
VerDate Sep<11>2014 15:19 Sep 11, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1](https://thefederalregister.org/doc/82_FR_42993/page/2.svg)
Document Created: 2018-10-24 14:13:19
Document Modified: 2018-10-24 14:13:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; extension of comment period. | |
| Dates | FDA is extending the comment period on the notice published August 14, 2017 (82 FR 37866). Submit either electronic or written comments by September 20, 2017. | |
| Contact | James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected] | |
| FR Citation | 82 FR 42818 |
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